Pharmaceutical products are often delivered or transferred through the use of an injection system, e.g., a syringe system. Many syringe systems are sold empty. In order to deliver or transfer pharmaceutical products it thus is necessary to aspirate a desired volume of pharmaceutical product into the syringe prior to the desired delivery or transfer. For example, if the desired pharmaceutical product is stored in a standard drug vial, it is necessary that the syringe system be provided with a needle or other means for accessing the interior of the drug vial in order to allow the pharmaceutical to be aspirated into the syringe system. This extra step is time consuming and may need to be undertaken by a pharmacist rather than by the healthcare practitioner who is actually responsible for the delivery/transfer of the pharmaceutical product. In order to eliminate this extra step, some pharmaceutical products in the market today are provided in pre-filled syringe systems that eliminate the need to aspirate the pharmaceutical product into the syringe system prior to delivery/transfer to the patient.
Pre-filled syringe systems can take a variety of forms, including pre-filled glass syringes, e.g., pre-filled HYPAK™ glass syringes from Becton Dickinson and Company, pre-filled plastic syringes, e.g., pre-filled ANSYR™ syringes from Hospira, Inc., and pre-filled cartridge syringes, e.g., pre-filled CARPUJECT™ and iSECURE™ syringe systems from Hospira, Inc.
Pre-filled glass syringes and pre-filled plastic syringes present potential transportation, handling, and storage issues due to the possibility that the position of the plunger rod can be inadvertently shifted resulting in either inadvertent ejection of the pharmaceutical product or inadvertent aspiration of environmental fluids into the syringe system. In order to minimize the risk of such inadvertent movement of the plunger rod, pre-filled syringes are typically placed into an overwrap packaging.
Pre-filled syringe systems that utilize pharmaceutical cartridges or ampoules, e.g., the CARPUJECT™ and iSECURE™ syringe systems sold by Hospira, Inc., utilize specialized cartridge assemblies. These cartridge assemblies typically include an ampoule containing the pharmaceutical product. The ampoule is typically closed at the proximal end by a plunger. The distal end of the ampoule is sealed by a pierceable membrane or diaphragm. A hub system is movably positioned on the distal end of the ampoule. The hub system includes a piercing needle designed to penetrate through the pierceable membrane or diaphragm when the hub system is moved from its inactivated position to an activated position. Movement of the hub system from the inactivated position to the activated position requires that the hub system and the ampoule be moved toward one another. The hub system further includes a flow pathway in fluid communication with the piercing needle. The flow pathway is in communication with a delivery end of the hub system that can include a variety of known pharmaceutical delivery devices, including hypodermic needles or luer connectors. Additional aspects of these syringe systems are described in U.S. Pat. Nos. 5,653,698 and 7,563,253, both of which are incorporated herein by reference in their entirety.
The inventors have identified certain improvements to pre-filled syringe systems.